Dexcom G5 APPROVED by FDA!
All text taken from the Dexcom press release that can be found in its entirety but this is the stuff you want to know. When you are finished reading this you can check out Dexcom's new G5 webpage.
SAN DIEGO, Aug. 25, 2015 /PRNewswire
FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System
Image from Dexcom.com
Dexcom announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers". These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.
About the Dexcom U.S. G5 Mobile Launch
- The G5 Mobile system is anticipated to begin shipping in late September 2015.
- All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.
- There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.
Image from Dexcom.com
"Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated and will be discussed in detail on the Q3-2015 earnings call in early November," remarked Sayer.
“Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple Watch™ and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before... We are excited for the promise this new technology holds for patients and caregivers.”
I'm working on getting you some G5 images, in the meantime check out the link below for my recent podcast conversation with Dexcom CEO Kevin Sayer... back soon.
Great news for the type diabetes community!
Added 8/25/15 10:36am: I got you three NEVER BEFORE seen Dexcom G5 images...
Added 8/26/16 11:53pm: I spoke with Dexcom EVP Steve Pacelli today. We talked about the G5 approval, launch and more.
Glucagon App for Caregivers
Eli Lilly has designed an app that helps caregivers to understand how to reconstitute and administer Glucagon. It's worth checking out.
Long before we had an OmniPod insulin pump or a Dexcom CGM we managed Arden's BGs with a syringe and a little meter. One day, armed with only those tools, I tried and failed to fight the evil Chinese food monster. Shortly after the meal Arden laid sleeping in her crib, having her afternoon nap.
In an instant things went from normal to not and Kelly and I found ourselves kneeling around Arden on the floor tending to a seizure. While Kelly was opening fast acting glucose gel, I was staring at our glucagon, incapable of recalling the steps I was taught in the Endo's office. Thankfully, the gel worked and we never needed the glucagon but you can be sure that I changed my perception that. "this could never happen to us" and taught myself how that little red kit worked the very next day.
I always suggest using outdated glucagon kits to practice with and once you have the process down, give the next one to your school nurse so they can do the same. While I don't think that an app can replace the experience holding that glass syringe in your hand and getting accustomed to how it feels, this app goes a long way toward getting you ready for the experience.
Take it from me, if the day comes when you need glucagon... you do not want to be reading instructions.
The app is available for iOS and Android.
One year after the experience I described Arden talked about what it was like to have a seizure. I captured her candid and impromptu conversation on video. It's an old video that is somewhat sad to watch, but even though current diabetes management technology goes a long way toward stopping things like this from happening - it's very worth understanding what you are guarding against.
Arden's Nine Year Diaversary
On this very date, some time after midnight in 2006, I remembered something that I meant to say to my wife Kelly but forgot to earlier in the day. Arden was two years old, we were on a family vacation and she had been very sick for days. Our family was gathered around a table playing a board game late at night, Arden was sleeping on Kelly's lap.
"Arden’s breath smells funny, metallic or maybe sweet..."
Moments after I spoke those words, all sense of joy left our world. A few hours later Arden was diagnosed by an ER doctor with type 1 diabetes.
One year later as the anniversary of that night approached, I started writing on the Internet about my life as the father of a child who lived with type 1. I posted my first blog at 3 am. I spoke in that first post of a high BG that was over 220 and I talked about that number like it wasn't really that high. Back then our diabetes technology consisted of a small meter and not much else, I was scared, our technology was lacking and 220 seemed safe as she slept. Safe in the short term that is.
Much thankfully, has changed since then...
Tonight Arden is sleeping in her bed, BG is 78 and steady. I'm bumping it up before I go to sleep with a short temp basal decrease on her Omnipod, I'd like to have it at 95 before I finish writing this. I'm watching her blood sugar in real-time on my iPhone at the moment. Again, much has changed in nine years, no more sneaking into rooms like a vampire.
My daughter has had type 1 diabetes for nine years and I've been sharing my life as her father for eight of them. I've seen this blog help many families and I have a sincere hope that it will help many more. Arden has always been generous and allowed me to share my experiences without reserve. Aside from the occasional request to leave out a detail, she lets me tell my story in the hopes that something we have learned or lived through may help you. I got my joy back years ago and I don't want you to be without yours for a second longer than you have to be. I believe very much that community support in all its forms, is key to finding balance and recapturing the joy you felt before diabetes arrived.
But my story is her story and she's made a request...
Arden no longer wants this blog to be adorned with a header image that depicts her as a four year old. A reasonable desire, I'm sure you agree. She made this small request at the beginning of 2015 and since then I've been working with an artist that I love to replace the art that is at the top of the blog, on Facebook, Twitter as well as my social media badges. The banners, profile images and Juicebox Podcast cover art are nearing completion and should begin popping up in the coming weeks. The artist has created a representation of that sweet picture of a four year old Arden, the one in the yellow top, that is reminiscent of the original. It was my goal for current readers to be reminded of that image and for new readers to not see Arden as a four year old.
Moving forward my goal for this blog and my new podcast remains the same as ever. I'll live my life as well as I can and when something happens that I believe would help you to live yours, I'll share it here and on the podcast (Which you guys are being so supportive of... thank you!). A podcast, a lot really has changed in nine years.
By the way, Arden's BG is now 98. I temp basal'd that low away like a champ... but then I've had nine years to practice.
Until there is a cure, I'll be here if you need me.
Dexcom Announces Google Collaboration
“This partnership has the potential to change the face of diabetes technology forever”
“Working together, we believe we can introduce products that will move us beyond our core Type 1 business to become the standard of care for all people living with diabetes”
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Initial products to be developed under the agreement will focus on minimizing both the cost and size of CGM body worn components. The products will be designed to be disposable, and will be intended for use across all diabetes markets. The goal is to empower more people to control their diabetes with real-time and actionable information by developing a low-cost, small, bandage-sized sensor that is connected to the cloud. By addressing these needs, we believe we will have the platform that can replace finger sticks and become the standard of care.”
Kevin Sayer
SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for people with diabetes, announced today that it has entered into an agreement with the life sciences team at Google to jointly develop a series of next-generation CGM products that are designed to be smaller and less expensive than existing technologies. These new products will incorporate Google's miniaturized electronics platform with DexCom's best-in-class sensor technology. This collaboration also provides an opportunity to better utilize the data generated by these CGM products to significantly improve the outcomes and reduce the costs associated with diabetes care.
I spoke with Kevin a few days after this announcement for the Juicebox Podcast. It's a great listen if you are interested in Dexcom technology. The show is available on iTunes and wherever you find your podcasts. You can also listen here with this player.
Six Nights of Sleep
The insanity of youth sports may have just saved my life...
I've lost track of how long it's been since I've had a revelation about type 1 diabetes parenting that I felt should be shared. It has bothered me that I haven't written as much over the past year on this blog, professionally and for fun as I expected that I would, but I've rationalized the drop off by telling myself that I didn't have much to say.
Today I have something to say
Last week very early on Thursday morning I drug myself out of bed after only sleeping for a few hours because of a stubborn blood sugar and turned on the shower. It was just before five in the morning and I was about to drive to the airport with my son Cole. Cole is fifteen and his baseball team was about to compete in a week long tournament in Georgia. Cole and Arden have both played in tournaments in the past that have required a night or two in a hotel but this was my first experience spending a full week away from home where my wife and I had to split up to care for our kids.
I went to Georgia, Kelly stayed in New Jersey
Initially the trip caused us some angst. The cost of spending a week in Georgia is oppressive and felt ridiculous when considering that Cole is only 15. There was the specter of Arden's Omnipods and Dexcom CGMs needing to be switched during my absence, not to mention that Kelly had to use precious vacation time so she could stay with Arden. But I digress, let's get back to me in the shower.
Cole making a crazy catch in centerfield - Georgia
I was standing in that shower last Thursday morning completely sapped of physical and mental resilience. Next month Arden will have type 1 diabetes for nine years and I am so far past the day where I ignorantly believed that I was the one human being on the planet that didn't need a good night's sleep, that I now exist day-to-day in a zombie like manner dragging myself to the next handful of hours of sleep. Never-the-less I dutifully washed myself and woke my son, we drove to the airport and made our way to Atlanta where I met up with my son's team, each parent that accompanied had their own ideas about how to pass the time in Georgia - I was no different.
We all attended the games but there was so much downtime. One group of lone dads took the opportunity to relive their youth; some families traveled together and took day trips in between games... I slept because I had just enough focus left to recognize that if I didn't I wasn't going to make it much longer. The first two nights I slept for close to twelve hours respectively, on the third night I crammed in ten hours. On Sunday afternoon, my brain restarted. Some fathers were sitting around talking about the election and I was following what they were saying. The conversation moved back and forth, the topics were deep and flowing and I was keeping up and having thoughts of my own. I had not felt like this in a very long time. I then remembered a few months prior having a (semi) conscience thought that I was unfocused most of the day and that I was having trouble thinking. One night, not too long ago, I recall sitting up with a low blood sugar and feeling like my heart was going to burst. Yet after only three days of sleep here I was able to keep up in a fast-paced and thoughtful conversation.
I took some ribbing over the week for my early to bed late to rise game plan but I was undeterred and I tried to explain my exhaustion to a few of the other dads, they did not come close to being able understand, though I could tell that they thought they did. Yesterday Cole and I flew home after seven days of baseball in the unrelenting Georgia heat. I spent six glorious nights sleeping on a sketchy Marriott mattress that in any other situation, I'd have thrown out a window. Today I am a new person but that's not the end of my story.
While I was sleeping Kelly and Arden were at home living
Arden swapped two Omnipods by herself while I was gone and Kelly applied her first Dexcom sensor! I was super proud of both of them but not surprised in the least at the deftness at which they handled the tasks. It turns out that by removing me from day-to-day life, we removed a few misconceptions that have been solidified by time. You see up until five seconds after Kelly inserted Arden's Dexcom sensor, Arden was sure that only I could do such a thing. Now she knows that Kelly can as well and I'm betting that Arden is now on her way to believing that she can too. The girls also had fantastic control of Arden's BGs during a week were Arden played or practiced softball almost everyday and we all know that in itself, is no small feat.
The only thing left for me to do is to find a balance that keeps me from sliding back into the brain fog that allowed me to fall so far from feeling human without allowing Arden's care to suffer. It's too nice feeling like this again and I can't and won't ever go back. You have no idea how relieving it is to write this today... I thought I had lost my ability to write. I would have been heartbroken by that feeling, you know, if my brain wasn't numb. Instead my life was drifting away like a slow iceberg trudging along without me noticing the direction that it was taking.
If you are a long time diabetes parent please talk to your loved ones and find a way to get yourself significant quantities of rest and please don't stop sleeping until you feel like yourself again. You aren't the only person on the planet that doesn't need sleep and the fog that you are in right now is very likely clouding your reactions, thoughts and ability to live well.
If you are a new diabetes parent, heed this warning. You will not be the exception to the human need for sleep. I thought I was for years and had it not been for this baseball tournament, I may have died prematurely still believing that I was. No matter how badly I want Arden's blood glucose to stay in range, not sleeping to accomplish those numbers can't be the answer. A balance must exist and I'm going to find it.